Adults 18 to 90, any sex, with Complicated Intra-Abdominal Infections, cIAIs. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0 hrPrimary· Predose (0 hr) on Day 1
All participants were to have sparse pharmacokinetics (PK) sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above lower limit of quantification (LLOQ). LLOQ for ATM was 0.1 microgram per milliliter (mcg/ml).
Group
Value
95% CI
ATM-AVI+ Metronidazole:Low AVI Dose Cohort
0.1
± NA
Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0.42 hrPrimary· 0.42 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI+ Metronidazole:Low AVI Dose Cohort
39.0
± 262.0
ATM-AVI + Metronidazole: High AVI Dose Cohort
39.4
± 58.1
Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 3.25 hrPrimary· 3.25 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI+ Metronidazole:Low AVI Dose Cohort
55.7
± 16.0
ATM-AVI + Metronidazole: High AVI Dose Cohort
58.5
± 36.3
Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 5 hrPrimary· 5 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: Low AVI Dose Cohort
28.8
± 23.9
ATM-AVI + Metronidazole: High AVI Dose Cohort
31.5
± 50.8
Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0 hrPrimary· Predose (0 hr) on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 nanogram per milliliter (ng/ml).
Group
Value
95% CI
ATM-AVI + Metronidazole: Low AVI Dose Cohort
24.9
± NA
Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0.42 hrPrimary· 0.42 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: Low AVI Dose Cohort
7852.6
± 279.2
ATM-AVI + Metronidazole: High AVI Dose Cohort
9801.5
± 61.8
Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 3.25 hrPrimary· 3.25 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: Low AVI Dose Cohort
9976.5
± 25.8
ATM-AVI + Metronidazole: High AVI Dose Cohort
12982.7
± 49.7
Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 5 hrPrimary· 5 hr Post dose on Day 1
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: Low AVI Dose Cohort
4086.6
± 35.3
ATM-AVI + Metronidazole: High AVI Dose Cohort
5549.0
± 76.6
Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 0 hrPrimary· Predose (0 hr) on Day 4
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: High AVI Dose Cohort
19.7
± 29.0
Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 2.75 hrPrimary· 2.75 hr Post dose on Day 4
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: High AVI Dose Cohort
46.4
± 19.5
Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 5 hrPrimary· 5 hr Post dose on Day 4
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: High AVI Dose Cohort
16.5
± 37.3
Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 4, 0 hrPrimary· Predose (0 hr) on Day 4
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
Group
Value
95% CI
ATM-AVI + Metronidazole: High AVI Dose Cohort
4048.8
± 24.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to the LFU visit (up to maximum of 38 days).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ATM-AVI+ Metronidazole: Low AVI Dose Cohort
Serious: 4/16 (25%)
Deaths: 0/16
ATM-AVI + Metronidazole: High AVI Dose Cohort
Serious: 5/18 (28%)
Deaths: 1/18
Serious adverse events (12 terms)
Reaction
System
ATM-AVI+ Metronidazole: Lo…
ATM-AVI + Metronidazole: H…
Intestinal ischaemia
Gastrointestinal disorders
—
—
Intra-abdominal haematoma
Gastrointestinal disorders
—
—
Pancreatitis acute
Gastrointestinal disorders
—
—
Abdominal wall infection
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Arterial injury
Injury, poisoning and procedural complications
—
—
Postoperative ileus
Injury, poisoning and procedural complications
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 2 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02655419.